MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number	400SMTSFT0506
Medical Device Problem Codes	Break (1069); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned smart coil was unable to determine the root cause of the reported difficulty detaching.Evaluation confirmed that the embolization coil was detached.The pet lock was separated, which is a result of a successful detachment attempt during the procedure.The reported broken embolization coil was not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The investigation findings do not lead to a clear conclusion about the cause of the reported difficulty detaching.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra microcatheter, a non-penumbra stent and another non-penumbra microcatheter.During the procedure, the physician placed a stent in the target vessel.The physician then attempted to advance the smart coil to frame the target location, but experienced resistance and also felt that the coil was stiff.The coil compartmentalized while framing; however, the physician was able to frame it after retracting and advancing it back into the aneurysm.The physician then detached the smart coil using the handle and pulled the pusher wire back after noticing the detachment markers to be separated.Under fluoroscopy, it was noticed that the smart coil was not actually detached and was stretched.It was reported that the physician was not satisfied with the placement of the stent, and therefore, attempted to remove the stent along with the smart coil, but the smart coil continued to stretch even after the stent was removed from the patient.Subsequently, the physician cut the smart coil using scissors and pushed it into the target location.A portion of the smart coil remained in the vessel; therefore, the physician stented this portion of the smart coil against the basilar artery and left and right posterior cerebral artery (pca).The procedure was completed using additional smart coils and the same handle.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12246451
• Report Number: 3005168196-2021-01684
• Device Sequence Number: 2772017
• Product Code: HCG
• UDI-Device Identifier: 00814548015149
• UDI-Public: 00814548015149
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2021
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2025
• Device Model Number: 400SMTSFT0506
• Device Catalogue Number: 400SMTSFT0506
• Device Lot Number: F99517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005